BEUDAMED
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    Filters Notified Body: 3 Ec International A.S. ×

    IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES S.A.

    Manufacturer
    45 Basic UDI-DIs·45 Devices·HTCert (Health Technology Certification Ltd), HTCert (Health Technology Certification Ltd), NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY, 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., and 3EC International a.s.

    2024-MDR/QS-050

    Certificate
    MDR QMS·HuBioMed Inc.·3EC International a.s.

    2017-MDD/QS-044/C, 2017-MDD/DE-045/C

    Certificate
    MDD Annex II (excluding section 4)·BNC KOREA, Inc.·3EC International a.s.·35 Basic UDI-DIs

    2023-MDR/QS-004

    Certificate
    MDR QMS·BNC KOREA, Inc.·3EC International a.s.

    2021-MDD/QS-023, 2021-MDD/DE-024

    Certificate
    MDD Annex II (excluding section 4)·BNC KOREA, Inc.·3EC International a.s.·25 Basic UDI-DIs

    No.2020-IVD/QS-008

    Certificate
    IVDD Annex IV (excluding sections 4, 6)·CTK Biotech Inc.·3EC International a.s.·1 Basic UDI-DI

    2024-MDR/QS-060

    Certificate
    MDR QMS·Vortran Medical Technology 1 Inc.·3EC International a.s.